Will Erectile Dysfunction Increase the Risk of Prostate Cancer

NCT ID: NCT03009123

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21558 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-05-06

Brief Summary

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The rationale for investigating the hypothesis that there is an association between erectile dysfunction (ED) and the subsequent development of prostate cancer is based on three assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in men with prostate cancer; 2) the development of ED and prostate cancer may have certain shared common risk factors; and 3) the use of testosterone for the treatment of ED has been suspected to be associated with prostate cancer development. Controversy exists over whether men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated the risk of developing prostate cancer for men with ED. The investigators, therefore, conducted a population-based longitudinal study with eight years' follow-up to examine this association and to evaluate the magnitude of the risk.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Erectile dysfunction group

Group contains men with physician-diagnosed erectile dysfunction

Erectile dysfunction

Intervention Type OTHER

Patients with ED are considered belonging to the exposure group.

General population men without ED

Men 50 years and older having no ED and pre-existing prostate cancer

No interventions assigned to this group

Symptomatic BPH group without ED

Men 50 years old older with symptomatic prostatic hypertrophy but with no ED nor pre-existing prostate cancer

No interventions assigned to this group

Interventions

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Erectile dysfunction

Patients with ED are considered belonging to the exposure group.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* men 50 years and older with no pre-existing prostate cancer

Exclusion Criteria

* less than 50 years old
* pre-existing prostate cancer
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Asia University

OTHER

Sponsor Role collaborator

National Central University, Taiwan

OTHER

Sponsor Role collaborator

Kuang Tien General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Victor C. Kok, MMedSc, MD, PhD, FACP

Ass. Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor C Kok, MD, PhD

Role: STUDY_DIRECTOR

Disease Informatics Research Unit, Asia University Taiwan

Locations

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Kuang Tien General Hospital

Taichung, , Taiwan

Site Status

Countries

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Taiwan

References

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Sairam K, Kulinskaya E, Boustead GB, Hanbury DC, McNicholas TA. Prevalence of undiagnosed prostate cancer in men with erectile dysfunction. BJU Int. 2002 Feb;89(3):261-3. doi: 10.1046/j.1464-4096.2001.01271.x.

Reference Type BACKGROUND
PMID: 11856107 (View on PubMed)

Saitz TR, Serefoglu EC, Trost LW, Thomas R, Hellstrom WJ. The pre-treatment prevalence and types of sexual dysfunction among patients diagnosed with prostate cancer. Andrology. 2013 Nov;1(6):859-63. doi: 10.1111/j.2047-2927.2013.00137.x. Epub 2013 Oct 11.

Reference Type BACKGROUND
PMID: 24127273 (View on PubMed)

Resnick MJ, Barocas DA, Morgans AK, Phillips SE, Chen VW, Cooperberg MR, Goodman M, Greenfield S, Hamilton AS, Hoffman KE, Kaplan SH, Paddock LE, Stroup AM, Wu XC, Koyama T, Penson DF. Contemporary prevalence of pretreatment urinary, sexual, hormonal, and bowel dysfunction: Defining the population at risk for harms of prostate cancer treatment. Cancer. 2014 Apr 15;120(8):1263-71. doi: 10.1002/cncr.28563. Epub 2014 Feb 7.

Reference Type BACKGROUND
PMID: 24510400 (View on PubMed)

Chou PS, Chou WP, Chen MC, Lai CL, Wen YC, Yeh KC, Chang WP, Chou YH. Newly diagnosed erectile dysfunction and risk of depression: a population-based 5-year follow-up study in Taiwan. J Sex Med. 2015 Mar;12(3):804-12. doi: 10.1111/jsm.12792. Epub 2014 Dec 5.

Reference Type BACKGROUND
PMID: 25475605 (View on PubMed)

Lee PH, Kok VC, Chou PL, Ku MC, Chen YC, Horng JT. Risk and clinical predictors of osteoporotic fracture in East Asian patients with chronic obstructive pulmonary disease: a population-based cohort study. PeerJ. 2016 Oct 27;4:e2634. doi: 10.7717/peerj.2634. eCollection 2016.

Reference Type BACKGROUND
PMID: 27812429 (View on PubMed)

Kok VC, Horng JT, Hung GD, Xu JL, Hung TW, Chen YC, Chen CL. Risk of Autoimmune Disease in Adults with Chronic Insomnia Requiring Sleep-Inducing Pills: A Population-Based Longitudinal Study. J Gen Intern Med. 2016 Sep;31(9):1019-26. doi: 10.1007/s11606-016-3717-z. Epub 2016 Apr 29.

Reference Type BACKGROUND
PMID: 27130621 (View on PubMed)

Kok VC, Sung FC, Kao CH, Lin CC, Tseng CH. Cancer risk in East Asian patients associated with acquired haemolytic anaemia: a nationwide population-based cohort study. BMC Cancer. 2016 Feb 4;16:57. doi: 10.1186/s12885-016-2098-3.

Reference Type BACKGROUND
PMID: 26846920 (View on PubMed)

Kok VC, Tsai HJ, Su CF, Lee CK. The Risks for Ovarian, Endometrial, Breast, Colorectal, and Other Cancers in Women With Newly Diagnosed Endometriosis or Adenomyosis: A Population-Based Study. Int J Gynecol Cancer. 2015 Jul;25(6):968-76. doi: 10.1097/IGC.0000000000000454.

Reference Type BACKGROUND
PMID: 25893280 (View on PubMed)

Kok VC, Horng JT, Huang HK, Chao TM, Hong YF. Regular inhaled corticosteroids in adult-onset asthma and the risk for future cancer: a population-based cohort study with proper person-time analysis. Ther Clin Risk Manag. 2015 Mar 26;11:489-99. doi: 10.2147/TCRM.S80793. eCollection 2015.

Reference Type BACKGROUND
PMID: 25848295 (View on PubMed)

Kok VC, Horng JT, Huang JL, Yeh KW, Gau JJ, Chang CW, Zhuang LZ. Population-based cohort study on the risk of malignancy in East Asian children with juvenile idiopathic arthritis. BMC Cancer. 2014 Aug 29;14:634. doi: 10.1186/1471-2407-14-634.

Reference Type BACKGROUND
PMID: 25174953 (View on PubMed)

Kok VC, Horng JT, Chang WS, Hong YF, Chang TH. Allopurinol therapy in gout patients does not associate with beneficial cardiovascular outcomes: a population-based matched-cohort study. PLoS One. 2014 Jun 4;9(6):e99102. doi: 10.1371/journal.pone.0099102. eCollection 2014.

Reference Type BACKGROUND
PMID: 24897240 (View on PubMed)

Kok VC, Horng JT, Lin HL, Chen YC, Chen YJ, Cheng KF. Gout and subsequent increased risk of cardiovascular mortality in non-diabetics aged 50 and above: a population-based cohort study in Taiwan. BMC Cardiovasc Disord. 2012 Nov 21;12:108. doi: 10.1186/1471-2261-12-108.

Reference Type BACKGROUND
PMID: 23170782 (View on PubMed)

Other Identifiers

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KTGH-ASIAU-obs-erectile

Identifier Type: -

Identifier Source: org_study_id

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